COVID-19 Vaccine Responses in PIDD Subjects

Common Variable Immunodeficiency Clinical Trial

Official title:

Vaccine-induced SARS-CoV-2-specific T Cell Responses in Patients With Primary Immune Deficiency Disease

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05321407
• Other study ID #: Pro00108422
• Secondary ID: R21AI168980
• Status: Recruiting
• Start date: September 24, 2021
• Est. completion date: December 31, 2024

Study information

• Verified date: June 2024
• Source: Duke University
• Contact: Guglielmo Venturi, PhD
• Phone: 919-613-6818
• Email: XLACOVIDvax[@]duke.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The goal of our study is to assess the cellular immune responses of participants with antibody deficiency disease before and after immunization with SARS-CoV-2 mRNA vaccines.

Description:

Individuals with primary and secondary antibody immunodeficiency are at higher risk for severe COVID-19 disease. Humoral immunity is thought to be the predominant protection against COVID-19, however mRNA vaccines have been shown to elicit both antibody and cellular responses.

The goal of our study is to assess the cellular immune responses of participants with antibody deficiency diseases, including X-linked agammaglobulinemia (XLA), common variable immunodeficiency (CVID), and secondary hypogammaglobulinemia, before and after immunization with SARS-CoV-2 mRNA vaccines.

Our aim is to examine SARS-CoV-2 spike-specific T cell immune responses before and after immunization with mRNA vaccines in a cohort of individuals with antibody deficiencies compared to healthy volunteers. Our secondary objectives include (1) detecting cellular immune response differences between immunized and infected participants, (2) observing cellular immune responses over time, and (3) comparing clinical outcomes between vaccination, infection, and underlying antibody deficiency. The results will show whether antibody deficiency individuals can mount T cell responses to SARS-CoV-2 vaccination or infection, data that are expected to inform health policy of SARS-CoV-2 implementation in immunocompromised individuals. Findings will further provide foundation for larger cohort studies of SARS-CoV-2 vaccination in other immunocompromised populations.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Months and older

Eligibility

Inclusion Criteria:

1. Diagnosis of antibody deficiency with confirmatory lab or genetic testing

2. Stable on immunoglobulin replacement therapy

3. Age >6 months and able to provide consent, or assent with parental consent if <18 years

4. Willing and able to receive the Pfizer BioNTech BNT162b2 mRNA or the Moderna mRNA-1273 vaccines

Exclusion Criteria:

(1) History of other chronic disease with depressed immune function or immune suppressive medication

Related Conditions & MeSH terms

• Agammaglobulinemia
• Common Variable Immunodeficiency
• CVID
• Immunologic Deficiency Syndromes
• Primary Immune Deficiency
• Primary Immunodeficiency Diseases
• X-linked Agammaglobulinemia
• XLA

Locations

Country	Name	City	State
United States	University of North Carolina, Chapel Hill	Chapel Hill	North Carolina
United States	Duke University	Durham	North Carolina
United States	University of South Florida	Saint Petersburg	Florida

Sponsors (5)

Lead Sponsor	Collaborator
Duke University	Jeffrey Modell Foundation, National Institute of Allergy and Infectious Diseases (NIAID), University of North Carolina, Chapel Hill, University of South Florida

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Spike (S) protein-specific T cell responses to stimulation with SARS-CoV-2 wild-type peptides (measured as a percentage of total T cells).		2 years
Primary	Spike (S) protein-specific T cell responses to stimulation with SARS-CoV-2 alpha variant peptides (measured as a percentage of total T cells).		2 years
Primary	Spike (S) protein-specific T cell responses to stimulation with SARS-CoV-2 beta variant peptides (measured as a percentage of total T cells).		2 years
Primary	Spike (S) protein-specific T cell responses to stimulation with SARS-CoV-2 delta variant peptides (measured as a percentage of total T cells).		2 years
Primary	Spike (S) protein-specific T cell responses to stimulation with SARS-CoV-2 omicron variant peptides (measured as a percentage of total T cells).		2 years
Secondary	S-specific T cell responses (as a percentage of total T cells) to SARS-CoV-2 vaccination in primary antibody deficiency over time.		2 years
Secondary	S-specific T cell responses (as a percentage of total T cells) to SARS-CoV-2 vaccination in secondary antibody deficiency over time.		2 years
Secondary	S-specific T cell responses (as a percentage of total T cells) to SARS-CoV-2 in infected participants.		2 years
Secondary	S-specific T cell responses (as a percentage of total T cells) to SARS-CoV-2 in vaccinated participants.		2 years
Secondary	Number of vaccinated participants who develop severe COVID-19 clinical outcomes.		2 years
Secondary	Number of infected participants who develop severe COVID-19 clinical outcomes.		2 years
Secondary	Number of antibody deficiency participants who develop severe COVID-19 clinical outcomes.		2 years